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Evos Mini-Fragment Plating System

by Smith & Nephew, Inc.

510(k) K140814

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK140814 Date7 May 2014ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2945-2020 FDA Class II initiated 24 Aug 2020

    Multiple or incorrect expiration dates were provided on the affected designation labels.

    • Terminated Z-0408-2018 FDA Class II initiated 29 Nov 2017

    One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRS
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

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